Breast CancerNCT07294703
Factors Associated With Breast Cancer Risks and Outcomes
An observational study of Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The purpose of this study is to learn more about risks and outcomes of breast cancer in people with different backgrounds. Tissue and blood will be collected from participants for research purposes. Participants will complete questionnaires during their standard medical care. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Survey
- How many people
- 750 participants
- Where
- 7 sitesUnited States
- Study dates
- 8 Dec 2025to 8 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: MSK research staff and/or treating clinicians will identify participants (anyone meeting inclusion criteria listed above) prior to or during their regularly scheduled visits (Breast radiology at time of initial biopsy, Surgery clinic visit, Medical Oncology clinic visit). A member of the MSK study team will approach the participants either in person or remotely to explain details of the study and answer any questions.
Who may be able to join
- A patient cannot be considered eligible for this study unless the following conditions are met.
- Patients with a suspicious breast finding who present to breast radiology at MSK for biopsy or any new breast cancer patient who is a surgical candidate seen at MSK.
- Women 18 years of age and older are eligible to participate in the study.
Who cannot join
- Patients presenting with a suspicious breast mass or breast cancer less than 1 cm.
- Patients presenting to clinic with only microinvasion
- Patients who are less than 18 years of age
- Patients unable to complete the survey, including IDMC patients.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Cancer Center Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Neha Goel, MD, MPH, 646-888-4298
- Recruiting
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York, 11725
Neha Goel, MD, MPH, 646-888-4298
- Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Neha Goel, MD, MPH, 646-888-4298
- Recruiting
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
Neha Goel, MD, MPH, 646-888-4298
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Neha Goel, MD, MPH, 646-888-4298
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, 10065
Neha Goel, MD, MPH, 646-888-4298
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, 11553
Neha Goel, MD, MPH, 646-888-4298
About this study
Official title: Genomic and Non-Genomic Factors Associated With Breast Cancer Risk Factors and Outcomes
The purpose of this study is to learn more about risks and outcomes of breast cancer in people with different backgrounds. Tissue and blood will be collected from participants for research purposes. Participants will complete questionnaires during their standard medical care. The study will not provide treatment for cancer or any other condition.
- Conditions
- Breast Cancer
- Being tested
- Survey
- Keywords
- Breast cancer, Memorial Sloan Kettering Cancer Center, 25-335
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Complete surveys:
- Baseline (within 6 months of enrollment)
- 1st follow-up survey (approx. 6 months to 12 months)
- 2nd follow-up survey and/or blood collection (approx. 3 years +/- 6 months)
- 3rd follow-up survey and/or blood collection (approx. 5 years +/- 6 months)
| Study group | Role | What they receive |
|---|---|---|
| Participants with a suspicious breast finding or new breast cancer diagnosis | Participants with a suspicious breast finding who present to breast radiology at MSK for biopsy or a participants with a new breast cancer diagnosis who is a surgical candidate seen at MSK. Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence Free Survival/RFS
RFS as defined by the STEEP 2.0 guidelines
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start8 Dec 2025
- Primary completion8 Dec 2031 (estimated)
- Study completion8 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neha Goel, MD, MPH, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294703
- Sponsor's protocol ID
- 25-335
- Status last verified
- Oct 2026
- First submitted
- 8 Dec 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomic and Non-Genomic Factors Associated With Breast Cancer Risk Factors and Outcomes
- ClinicalTrials.gov ID
- NCT07294703
- Acronym / sponsor ID
- 25-335
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Memorial Sloan Kettering Cancer Center, 25-335
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 8 Dec 2031 (estimated)
- Study completion
- 8 Dec 2031 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn more about risks and outcomes of breast cancer in people with different backgrounds. Tissue and blood will be collected from participants for research purposes. Participants will complete questionnaires during their standard medical care. The study will not provide treatment for cancer or any other condition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with a suspicious breast finding or new breast cancer diagnosis | – | Other: SurveyParticipants with a suspicious breast finding who present to breast radiology at MSK for biopsy or a participants with a new breast cancer diagnosis who is a surgical candidate seen at MSK. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MSK research staff and/or treating clinicians will identify participants (anyone meeting inclusion criteria listed above) prior to or during their regularly scheduled visits (Breast radiology at time of initial biopsy, Surgery clinic visit, Medical Oncology clinic visit). A member of the MSK study team will approach the participants either in person or remotely to explain details of the study and answer any questions.
Key inclusion criteria (3 listed)
- A patient cannot be considered eligible for this study unless the following conditions are met.
- Patients with a suspicious breast finding who present to breast radiology at MSK for biopsy or any new breast cancer patient who is a surgical candidate seen at MSK.
- Women 18 years of age and older are eligible to participate in the study.
Key exclusion criteria (4 listed)
- Patients presenting with a suspicious breast mass or breast cancer less than 1 cm.
- Patients presenting to clinic with only microinvasion
- Patients who are less than 18 years of age
- Patients unable to complete the survey, including IDMC patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyComplete surveys: * Baseline (within 6 months of enrollment) * 1st follow-up survey (approx. 6 months to 12 months) * 2nd follow-up survey and/or blood collection (approx. 3 years +/- 6 months) * 3rd follow-up survey and/or blood collection (approx. 5 years +/- 6 months) | Other | Participants with a suspicious breast finding or new breast cancer diagnosis |
Primary outcome
Recurrence Free Survival/RFS
Time frame: 5 years
RFS as defined by the STEEP 2.0 guidelines
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neha Goel, MD, MPH principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neha Goel, MD, MPH (646-888-4298, goeln1@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence Free Survival/RFS (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.